The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC)
Shots:
- The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC)
- The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3% & OS of 2.322yrs. vs 1.900yrs. & a P-III confirmatory trial
- Enlituo (CMAB009), a recombinant EGFR mAb developed in partnership with Mabpharm, is categorized as a 2.4 class modified biologic & is produced by utilizing a protein production technology that prevents glycosylation modification which results in hypersensitivity
Ref: Simcere Zaiming | Image: Simcere Zaiming
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
